HR191
NOTES
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JOB DESCRIPTION
Forms must be downloaded from the UCT website: http://www.uct.ac.za/depts/sapweb/forms/forms.htm
This form serves as a template for the writing of job descriptions.
A copy of this form should be kept on file in your office.
For re-evaluations, this form must be sent to your relevant HR Advisor/Officer
POSITION DETAILS
Position Title (current title)
Project co-ordinator
Status of Post (tick)
New Post
Job Grade (current grade)
10
Faculty (if applicable)
Health Sciences
Department
Medicine
Section (if applicable)
Division of Clinical Pharmacology
Date of Compilation
22.04.2012
x
Re-evaluation
FOR OFFICE USE
Job Title
Date of Grading
Grading Result
ORGANOGRAM
Principal Investigator
Prof. Karen Barnes
Data manager
Ms Lesley Workman
Lead investigator
Dr Eric Decloedt
Internal quality control
monitor
Ms Liz Allen
Project co-ordinator
Study staff nurse
To be named
PURPOSE
The principle task of the project co-ordinator is to coordinate and manage clinical research
projects in the Division of Clinical Pharmacology. This task includes project coordination, staff
supervision, clinical and administrative research duties as well as data management.
22 April 2012
Page 1 of 5
HR191
JOB CONTENT
Key Performance Areas
1) Project coordination
2) Staff supervision
04 April 2012
% of
time
spent
20%
15%
Activities / Objectives / Tasks
Results / Outcomes
Competencies
a) Coordinates the implementation
of the research protocol in
relation to the objectives
b) Assists with the development of
mechanisms to facilitate
achievement of study objectives
c) Provides input to discussions
around study budget and
expenditure
d) Arranges consenting, enrolment
and follow-up schedules
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Relevant data collected to satisfy
study objectives
Useful input given with regard to
budgets
Consent, enrolment and follow-up
visits scheduled according to the
protocol
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a) Participates in staff job
assignments
b) Oversees work schedules
c) Supervises staff in relation to
study specific activities
d) Assists with the performance
assessments of relevant study
staff and provide constructive
feedback to staff
e) Assists with the co-ordination of
activities related to human
resource provision including
recruitment of temporary staff
f) Assists with the coordination of
activities related to human
resource maintenance in to
regard to conflict resolution
g) Assists with the management of
staff with regards to leave,
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Work schedules prepared for all
staff
Training needs and staff grievances
identified and relevant solutions
determined and delivered
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Good Clinical Practice
certification
Applicable research
experience
Good communication
skills
Leadership skills
Attention to detail
Leadership,
coordination and
supervisory skills
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absenteeism and overtime
3) Participant
management and clinical
research duties
4) Research
administrative duties (with
delegation to admin
support as required)
04 April 2012
30%
20%
a) Works with the clinical
investigators and the study staff
nurse to recruit adequate
numbers of participants
b) Provides information regarding
study to inform and attract
potential study participants
c) If qualified, may provide back-up
clinical duties according to
qualification
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a) Creates and maintains systems
for the day-to-day operation of
the research activities
b) Ensures that Essential
Documents, progress reports
and any other relevant
documents are prepared and
submitted timeously and
meticulously to meet study
requirements
c) Documents study activities (e.g.
meetings, training sessions and
decisions)
d) Sets up, maintains and archives
the investigator files.
e) Liaises with internal and external
monitors
f) Liaises between the clinical,
cardiology, laboratory and
pharmacy teams, and with the
Sponsor as required.
g) Sources and maintains trial
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Recruitment of the required number
of study participants within the
planned screening period
Correct submission of adverse
events to relevant parties
If qualified, clinical duties performed
according to study role
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Organization, management and
participation in research planning
meetings
Development and maintenance of
written and electronic records of
research activities
Effective communication between
the site team, committees,
organizations and funders relating
to research activities
Adequate maintained trial
equipment, supplies and ward
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Good Clinical Practice
certification
Applicable research
experience
Good communication
skills
Leadership skills
Attention to detail
Good Clinical Practice
certification
Administrative and
management skills
Good communication
and interpersonal
skills
Attention to detail
Time management
Writing and computer
skills
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equipment and consumables in
consultation with the relevant
parties
h) Maintains the function of the
ward related to specific trial(s),
including access control,
emergency procedures,
recreation facilities, catering and
preparations for admission of
participants
e) Prepares facilities and staff for
external audits, monitoring visits
and site visits
i) Manages flight, travel and/or
accommodation for research
related meetings if required
5) Data management
04 April 2012
15%
a) Oversees clinical data collection
and CRF completion in line with
SOPs and regulatory
requirements
b) Ensures adverse event reporting
is according to the protocol and
regulatory requirements
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Development and maintenance of
accurate clinical records (source
and CRF)
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Attention to detail
Good Clinical Practice
certification
Administrative and
management skills
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MINIMUM REQUIREMENTS
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Health sciences qualification or equivalent
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Good Clinical Practice (GCP) training
Minimum Experience
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At least 2 year project management experience
Advantageous
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Clinical trial experience, particularly Phase I studies
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Able to speak Xhosa
Minimum Qualifications
Compiled by
PRINT NAME
Dr Eric Decloedt
Approved by
Prof Karen Barnes
AUTHORITY
SIGNATURE
CONTACT NO.
021-406 6355
DATE
04 April 2012
021- 406 6633
04 April 2012
Reviewed by
Document1
7 February 2016